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Global Adverse Event Reports of Breast Implant–Associated ALCL: An International Review of 40 Government Authority Databases

Srinivasa, Dhivya R. M.D.; Miranda, Roberto N. M.D.; Kaura, Arminder B.A.; Francis, Ashleigh M. M.D.; Campanale, Antonella M.D.; Boldrini, Rosaria M.D.; Alexander, Janette M.D.; Deva, Anand K. M.D.; Gravina, Paula R. M.D.; Medeiros, L. Jeffrey M.D.; Nast, Karen R.N.; Butler, Charles E. M.D.; Clemens, Mark W. M.D.

Plastic & Reconstructive Surgery: May 2017 - Volume 139 - Issue 5 - p 1029–1039
doi: 10.1097/PRS.0000000000003233
Breast: Original Articles
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Discussion

Background: Tracking world cases of breast implant–associated anaplastic large cell lymphoma (ALCL) is currently limited to patient registries at a few academic centers, dependent upon patient referral and case reports in the literature. The purpose of this study was to review and compare federal database adverse event reports of breast implant–associated ALCL encompassing the major breast implant markets worldwide.

Methods: Federal implantable device regulatory bodies were contacted and database queries were performed for 40 countries. Demographics, device characteristics, pathology, treatment modalities, and outcomes were assessed when available.

Results: For the countries queried, 363 unique cases were reported for breast implant–associated ALCL. Search terms “anaplastic” and “ALCL” were queried of the U.S. Manufacturer and User Facility Device Experience (MAUDE) database and yielded 258 unique cases as of September 2015, of which only 130 had pathologic markers performed. Implant surface was textured significantly more than smooth (50 percent versus 4.2 percent; p = 0.0001). Treatment, when reported (n = 136), included explantation [n = 125 (91.9 percent)], chemotherapy [n = 42 (30.8 percent)], radiation therapy [n = 25 (18.4 percent)], and/or stem cell transplant [n = 9 (6.6 percent)], and five deaths were reported.

Conclusions: Federal reporting of breast implant–associated ALCL has limitations in providing clinical history, treatment, and oncologic follow-up. Worldwide and country-specific total and textured implant sales data are needed to determine critical incidence and prevalence analysis. International multi-institutional collaborations and centralized tissue consortiums working in concert with federal authorities are necessary to acquire accurate complete data on breast implant–associated ALCL.

Ann Arbor, Mich.; Houston, Texas; Rochester, Mich.; Silver Spring, Md.; Rome, Italy; Sydney, New South Wales, Australia; and Salvador, Brazil

From the Department of Plastic Surgery, University of Michigan; the Departments of Hematopathology and Plastic Surgery, The University of Texas M. D. Anderson Cancer Center; the Department of General Surgery, University of Texas, Houston; the Oakland University William Beaumont School of Medicine; the Plastic and Reconstructive Surgery Branch, Office of Device Evaluation, and Product Evaluation Branch II, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, U.S. Food and Drug Administration; the Ministry of Health, General Directorate of Medical Device and Pharmaceutical Service, Unit V, Medical Device Vigilance System and Inspections; the Department of Plastic Surgery, Macquarie University; and the Medical School of Federal University of Bahia.

Received for publication February 22, 2016; accepted October 17, 2016.

Disclosure: Dr. Deva is a consultant to Allergan, Mentor (J&J), and KCI (Acelity). All other authors report no conflicts of interest.

A “Hot Topic Video” by Editor-in-Chief Rod J. Rohrich, M.D., accompanies this article. Go to PRSJournal.com and click on “Plastic Surgery Hot Topics” in the “Digital Media” tab to watch. On the iPad, tap on the Hot Topics icon.

Mark W. Clemens, M.D., Department of Plastic Surgery, 1400 Pressler Street, Unit 1488, M. D. Anderson Cancer Center, Houston, Texas 77030, mwclemens@mdanderson.org

©2017American Society of Plastic Surgeons